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Further explanatory guidance for Diagnostic Radiopharmaceutical (RP) Investigation Medicinal Products (IMPs) and Good Manufacturing Practice (GMP) requirements.
Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
This is a work sharing model for the co-ordinated assessment of a generic application that has been filed with multiple Access Consortium agencies.
We are allowing alternative courses of actions for manufacturing or laboratory equipment during the outbreak.
Sets out the process for pharmaceutical companies to appeal against decisions made by the Secretary of State for Health and Social Care.
Guidance for local partnerships on how to review adult drug and alcohol related deaths and near-fatal overdoses to prevent future deaths.
Guidance on how Pharmacy First will help pharmacies support their communities, with information on the new clinical pathways and fee structure.
Explainer for industry on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Sets out the government's current position on the use of DEXA scans in the UK.
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
How to use RamaXL, including system availability, running reports and how to subscribe.
Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Which product type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Submitting annual reports on sales of electronic cigarettes and refill containers.
Report showing opportunities and challenges for community pharmacy teams to further support the public’s health.
Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.
The MHRA has published advice for patients and healthcare professionals
Do not include personal or financial information like your National Insurance number or credit card details.
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